BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEURO SECTOR FIXATION DEVICE

    K Number: K833522 · Decision May 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    61
    Review Days
    249

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    Basic Information

    Device Name
    NEURO SECTOR FIXATION DEVICE
    K Number
    K833522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1240
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Technology Laboratories, Inc.
    Date Received
    September 19, 1983
    Decision Date
    May 25, 1984
    Product Code
    GXW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GXW Echoencephalograph

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